HSHS Follow-up study
Key information
Chief Investigator: Professor Paul Ramchandani and Dr Christine O’Farrelly
Sponsor: University of Cambridge
ICTU collaboration: Statistics
Study website: Healthy Start, Happy Start
Trial registration: IRAS Number 310487
Status: Analysis
This study builds on the success of a previous trial: Healthy Start, Happy Start (HSHS; Ref 13/04/33; 2014-2019); which used a two-arm, parallel group, assessor-blind, randomised controlled trial design to test the clinical and cost effectiveness of a video feedback intervention (VIPP-SD) for parents of young children (12-36 months) at risk of behaviour problems. This follow-up study will assess the long-term clinical and cost-effectiveness of the intervention in a Bayesian analysis framework.
All participants in the original trial are eligible for participation in this follow-up study and have already been recruited from NHS services across six NHS sites in the UK. Target population: Young children who were aged 12-36 months when recruited to the original HSHS RCT and who had high levels of behaviour problems (originally recruited on the basis of scoring in the top 20% of population norms for the Strengths and Difficulties Questionnaire externalising subscale) and their caregiver(s). Children’s teachers will also be asked to complete a short questionnaire.
The primary objective is to assess whether, compared to usual care in the NHS, a brief parenting intervention (VIPP-SD) leads to long-term lower levels of behaviour problems in young children who are at high risk of developing these problems (five years post-randomisation – children aged six to nine years old). The results for the study are expected to be published by the end of the year.